Solaraze 3% gel

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Diclofenac sodium

Disponibil de la:

Almirall, S.A.

Codul ATC:

D11AX18

INN (nume internaţional):

Diclofenac sodium

Dozare:

3 percent

Forma farmaceutică:

Gel

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

diclofenac

Statutul autorizaţiei:

Marketed

Data de autorizare:

2003-07-11

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLARAZE 3%, GEL
Diclofenac Sodium 3% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor of pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Solaraze is and what it is used for
2.
What you need to know before you use Solaraze
3.
How to use Solaraze
4.
Possible side effects
5.
How to store Solaraze
6.
Contents of the pack and other information
1. WHAT SOLARAZE IS AND WHAT IT IS USED FOR
Solaraze is a non-steroidal anti-inflammatory dermatological gel. When
applied to the skin, Solaraze
gel is used to treat a skin problem known as actinic or solar
keratosis that is caused by long-term sun
exposure.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLARAZE
DO NOT USE SOLARAZE

If you are allergic to diclofenac or any of the ingredients of this
medicine (listed in section 6).

If you have had an allergic reaction such as skin rash (nettle rash),
breathing difficulties
(wheezing) or runny nose (allergic rhinitis) after taking aspirin or
any other non-steroidal anti-
inflammatory agents.

If you are in the final 3 months of your pregnancy.
WARNINGS AND PRECAUTIONS

The possibility of systemic side effects from application of Solaraze
cannot be excluded if the
product is used on large areas of skin and over a prolonged period.
Consult your doctor if:

you have, or have had in the past, a stomach ulcer or bleeding from
the stomach.

you have heart, liver or kidney problems.

you have any type of bleeding disorder or bruise very easily.

Avoid sun exposure, including tanning salons, when

Caracteristicilor produsului

Health Products Regulatory Authority
16 March 2021
CRN009ZW2
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solaraze 3% gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 30 mg diclofenac sodium (3% w/w).
Excipient(s) with known effect:
1 g of gel contains 10 mg of benzyl alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
A clear, transparent, colourless or pale yellow gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of actinic keratosis (AK).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_USE IN ADULTS: _Solaraze is applied locally to the affected area
twice daily, with the gel smoothed into the skin gently. The
amount needed depends on the size of the affected area. Normally 0.5
grams (the size of a pea) of the gel is used on a 5 cm x
5 cm lesion site. The maximum daily amount of 8 grams of product
allows simultaneous treatment of up to 200 cm² skin
surface area.
The usual duration of therapy is from 60 to 90 days. Maximum efficacy
has been observed with treatment duration towards
the upper end of this range. Complete healing of the lesion(s) or
optimal therapeutic effect may not be evident for up to 30
days following cessation of therapy.
_USE IN THE ELDERLY:_ The usual adult dose may be used.
_PAEDIATRIC POPULATION:_ AK is a condition not generally seen within
the paediatric population and was not studied. Therefore,
dosage recommendations and indications for the use of Solaraze have
not been established for use in children.
4.3 CONTRAINDICATIONS
Solaraze is contraindicated in patients with a known hypersensitivity
to diclofenac, benzyl alcohol, macrogol monomethyl ether
350 and/ or sodium hyaluronate.
Because of cross-reactions, the gel should not be used by patients who
have experienced hypersensitivity reactions such as
symptoms of asthma, allergic rhinitis or urticaria, to acetylsalicylic
acid or other non-steroidal anti-inflammatory agents.
The use of Solaraze is contraindicated during the third trimest